Health care providers, lab personnel, and lab test developers should be aware that biotin, often found in dietary supplements, can significantly interfere with certain lab tests and cause incorrect test results which may go undetected.

The FDA has issued an updated safety communication, UPDATE: The FDA Warns that Biotin May Interfere with Lab Tests, that discusses concerns with biotin interference in certain laboratory tests and provides recommendations for consumers, health care providers, lab personnel and lab test manufacturers and developers. Since the 2017 safety communication, some lab test developers have been successful at mitigating the biotin interference of their assays, but others have not yet addressed it.

The FDA remains concerned about certain laboratory tests that have not addressed the risk of biotin interference. For example, the FDA has continued to receive adverse events reports indicating biotin interference caused falsely low troponin results.  In an effort to increase transparency about this clinically important interference, the FDA has decided to notify the public about troponin assays that have not addressed the risk of biotin interference.

The following table lists the FDA listed troponin In Vitro Diagnostic Devices that are subject to biotin interference but have not addressed this risk.